Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition
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ClinicalTrials.gov Identifier: NCT01093989 |
Recruitment Status
:
Completed
First Posted
: March 26, 2010
Last Update Posted
: June 1, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | March 24, 2010 | |||
First Posted Date ICMJE | March 26, 2010 | |||
Last Update Posted Date | June 1, 2015 | |||
Study Start Date ICMJE | June 2010 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Hemoglobin change, anemia prevalence, and socioemotional behavior in the immediate iron vs. delayed iron groups [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01093989 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition | |||
Official Title ICMJE | Acute vs. Delayed Iron Therapy: Effect on Iron Status, Anemia and Cognition | |||
Brief Summary | The research questions to be answered by this study are:
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Detailed Description | The study population in this study will be children who are enrolled in our ongoing study of cerebral malaria and severe malarial anemia, "Pathogenesis of cognitive/neurologic deficits in central nervous system malaria", underway in Kampala, Uganda. The pathogenesis study seeks to address the question of why children with severe malaria have later problems in thinking. The study we are now proposing will build on this study by assessing whether children with severe malaria have iron deficiency, and if they do, whether treatment with iron at the time of malaria is less effective than treatment one month later. We believe that treatment one month later may be more effective because there is data that shows that the inflammation that occurs with a malaria episode may decrease the body's ability to absorb iron in the gut and to send iron to the places it is needed, like the bone marrow and the brain. We are doing this study to see if our hypothesis about more effective iron treatment if it is delayed is correct and assessing anemia prevalence, iron status, and long-term neurobehavioral development as outcomes. We have three study groups: children with cerebral malaria, children with severe malarial anemia, and healthy community control children. Children found to be iron deficient will be randomized to receive iron (as ferrous sulphate syrup) either immediately or at their one-month follow-up visit. At 1-, 6, and 12-month follow-up visits changes in iron and inflammation indicators will be assessed. At the 6- and 12-month visits, neurocognitive behavior will also be evaluated and compared between the immediate vs. delayed iron groups. Malaria morbidity will be assessed via home visits during the period of iron supplementation and via clinic monitoring for the duration of the study. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) |
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Condition ICMJE |
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Intervention ICMJE | Dietary Supplement: Ferrous Sulphate Syrup
Iron therapy will consist of a three-month course of ferrous sulphate syrup. For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight. |
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Study Arms |
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Publications * | Cusick SE, Opoka RO, Ssemata AS, Georgieff MK, John CC. Comparison of iron status 28 d after provision of antimalarial treatment with iron therapy compared with antimalarial treatment alone in Ugandan children with severe malaria. Am J Clin Nutr. 2016 Mar;103(3):919-25. doi: 10.3945/ajcn.115.117820. Epub 2016 Feb 3. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
239 | |||
Original Estimated Enrollment ICMJE |
300 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Severe malarial anemia
Community control children
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Sex/Gender |
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Ages | 18 Months to 5 Years (Child) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Uganda | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01093989 | |||
Other Study ID Numbers ICMJE | 0909M72852 1U01HD064698-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Minnesota - Clinical and Translational Science Institute | |||
Study Sponsor ICMJE | University of Minnesota - Clinical and Translational Science Institute | |||
Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |||
Investigators ICMJE |
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PRS Account | University of Minnesota - Clinical and Translational Science Institute | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |